目的 验证抗狂犬病毒单克隆抗体(单抗)中残留宿主细胞蛋白（host cell protein，HCP) ELISA定量检测方法。方法 使用商用中国仓鼠卵巢细胞HCP残留ELISA检测试剂盒，测定2种针对不同表位的抗狂犬病毒单抗原液中的残留HCP，并验证该方法的专属性、准确度、精密度、线性、耐用性、检测限及定量限。结果 2种抗狂犬病毒单抗发酵液稀释10 000倍后检出的HCP含量分别为31.42和19.36 ng/ml。制剂溶液、HEK293F和E.coli培养上清液中未检出HCP。 3种浓度的HCP加标供试品的加标回收率均在80%~120%之间。3种浓度的HCP加标供试品重复性检测结果及中间精密度检测结果相对标准偏差均＜20%。分别对3次残余HCP检测绘制四参数标准曲线，决定系数均＞0.990。在一定范围内改变孵育时间和显色时间，HCP测定结果在合理的偏差范围内。检测限和定量限分别为2和3 ng/ml。结论 抗狂犬病毒单抗中HCP残留量的ELISA定量检测方法专属性、准确度、精密度、线性及耐用性良好。

Objective To verify a quantitative ELISA in determination of the residual host protein (HCP) in anti-rabies virus monoclonal antibody (mAb). Methods The commercial Chinese hamster ovary cell HCP ELISA kit was used to determine the residual HCP in the stock solution of 2 anti-rabies virus mAbs targeting different epitopes, and the specificity, accuracy, precision, linearity, robustness, limit of detection(LOD) and limit of quantitation (LOQ) of the method were verified. Results The HCP content detected after diluting the fermentation broth of 2 anti-rabies virus mAbs by 10 000 times was 31.42 and 19.36 ng/ml, respectively. HCP was not detected in the preparation solution, and the culture supernatant of HEK293F and E. coli. The recoveries of the spiked samples with 3 different HCP concentrations were between 80% and 120%. The relative standard deviation of the repeatability test results and the intermediate precision test results of the spiked samples with 3 different HCP concentrations were all＜20%. The four-parameter standard curves were drawn for 3 HCP residual tests respectively, and coefficient of determination were all 0.990.The HCP test results were within a reasonable deviation range when the incubation time and the developing time were changed in a certain range. The LOD and LOQ were 2 and 3 ng/ml, respectively. Conclusion A quantitative ELISA detection method for residual HCP in anti-rabies virus mAb is verified, which shows good specificity, accuracy, precision, linearity, and robustness.